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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL VASCULAR UNKNOWN DUMMY MATERIAL

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TELEFLEX MEDICAL VASCULAR UNKNOWN DUMMY MATERIAL Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Extravasation (1842); No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device is not being returned investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
Per article: a (b)(6) female presented to the emergency department after a traumatic fall with symptoms of an acute stroke. Iv access failed and humeral io access was obtained using the ezio device and placement confirmed (no size of needle indicated). Contrast media was injected at 3. 5 ml/sec and during scan an extravasation of approximately 20 ml of contrast was noted within the gleno-humeral joint. The patient denied post procedural pain, and physical exam failed to reveal a neurological or vascular deficit, either immediately after the scan, the following day or one-week post-procedure. The exact cause of the extravasation was unknown with possible causes being 1) the humeral io needle can pass through the subdeltoid bursa during placement. Contrast passing retrograde along the ion tract could then enter the joint space via its connection to the bursa 2) a change in orientation of the driver during placement may have widened the needle tract 3) contrast passed directly into the joint space through an interruption in the periarticular bone.
 
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Brand NameVASCULAR UNKNOWN DUMMY MATERIAL
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key7695021
MDR Text Key114214917
Report Number1036844-2018-00192
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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